1. Field of the Invention
The present invention relates to a diagnostic analyzer, preferably a desk top analyzer. More particularly, the present invention relates to a diagnostic analyzer having removable holders that include a probe tip dispenser, a fluid supply section and a test element recess in the same line of travel. The invention also relates to an analyzer having a centrifuge thereon.
2. Description of the Related Art
Desktop analyzers, particularly for veterinary use and point of care (POC) human use, are known in the art. For example, the Abaxis Vetscan™ and Hemagen Analyst™ are both desktop analyzers for veterinary use. The Vitros® DT-60 is a desktop analyzer manufactured by Ortho-Clinical Diagnostics Corp. Other known analyzers include those POC analyzers described in U.S. Pat. Nos. 5,968,329, 5,747,666, 5,980,830 and 5,787,015, all of which are incorporated by reference in their entireties. U.S. Pat. No. 4,965,049 also discloses a modular analyzer system. U.S. Pat. No. 5,983,734 discloses a modular automated diagnostic system. U.S. Patent Application Publication No. 2002/0098116 ('116 publication) describes a biochemical analysis system that includes a circular sample tray and a removable sample cartridge. EP 458 138 A2 discloses a diagnostic system that includes a slide compartment having a graduated microcup and pipette tip opening. U.S. Pat. No. 4,797,257 describes analyzers and their components that use slides as test elements. U.S. Pat. Nos. 5,741,708, 5,244,633, and 5,736,403 all disclose analyzers having concentric rotors. These publications are also incorporated by reference in their entireties.
Known diagnostic systems, such as those described above, have generally adequately addressed size issues but often at the expense of functionality, test menu, and productivity, or vice versa. Most known systems perform tests serially on a single patient sample, significantly limiting walk away time for the user to perform other work tasks. These analyzers usually employ a number of dedicated subsystems within the analyzer to perform discrete functions such as sample storage and positioning, reagent storage, and waste collection among others. In some cases, multiple analyzer systems are required to perform a variety of test menus needed in the lab, for example, separate systems to perform immuno rate or electrolyte assays.
In many known systems, whole blood samples must be prepared (e.g., diluted or centrifuged) prior to testing, further limiting the user's productivity. Reagent formats can be individual test strips (e.g., such as dry-slide technology), which offer the most cost effective solution and test flexibility, or multiple test formats (e.g., such as the Abaxis Vetscan™ rotor), which limit selective assay testing, and, as a result, drive up test costs. Liquid systems may compromise analytical performance when dealing with patient sample background interference compared to analyzers that use a dry-slide format. However, there are some tests which are incompatible with dry formats and therefore must use wet or liquid formats.
With systems that require separation prior to testing, separation of the sample into its components, such as blood into serum or plasma, is usually accomplished as a pre processing step by a lab technician. Centrifugation is the more common method used. The sample, such as whole blood contained in a sample tube is placed into a high-speed centrifuge to perform the separation, which can take varying amounts of time depending on the centrifuge's speed. Known analyzers can also include microcentrifuges such as described in U.S. Pat. No. 4,933,291 which describes a device that allows whole blood sample to be aliquoted into a centrifugable pipette tip. The pipette tip is then engaged by a high-speed drive that rotates the tip along its center axis. As the tip rotates, blood cells from plasma are forced upward along the angled surface of the tip into a trap or cavity near the top of the tip. After spinning, the separated plasma is then dispensed from the bottom of the tip. Published Patent Application No. 2001/0019842 discloses a microcentrifuge for separating whole blood.
There is a need for small, portable in vitro diagnostic systems that are capable of automatically performing a wide range of analysis, preferably for both human and animal health care providers, and provide the flexibility to execute a variety of operations on patient samples with a high degree of simplicity and cost effectiveness. There are a number of factors that drive the need for improved products including:
Cost Pressures—Lower cost testing solutions that more effectively utilize system reagents and operation.
Ease of Use—Users at the POC and veterinary labs are often less skilled than most technicians working in large lab operations and often perform a wide range of lab and office functions. Systems utilized in these labs must be simple to use but offer a high degree of functionality. Systems that are easy to use with little maintenance or preparation of both sample and instrument are advantageous.
Increased Test Menu Capability—Systems are needed that can perform a wide range of tests without compromising analytical performance due to test format limitations. Current systems penalize the user due to their inflexibility to accommodate individual and panel tests without additional reagent waste associated with pre-configured test formats (e.g., the Abaxis Vetscan™ rotor or the Hemagen Analyst™ Panels+test rotor).
Size—Lab space is often very limited and portability is often a factor allowing the analyzer to be used at the patient location.
In developing such systems that achieve the above factors, there is a need to minimize the number of moving parts to save on costs and minimize space requirements. Known analyzers having removable holders (e.g., EP 458 138 A2) that include components such as slides, probe tips and sample sources do not have the components arranged in the same line of travel which results in an additional direction of motion for each subsystem. Other known analyzers (e.g., U.S. Publication No. 2002/0098116) also do not include components arranged in the same line of travel thus resulting in an additional direction of motion for subsystems to access the components. In addition, not all of the necessary components (e.g., probe tips) are arranged on the same removable holder. For analyzers requiring separation of the sample before analysis, known analyzers have not been able to incorporate a separating device such as a centrifuge, into the analyzer in a manner that allows the analyzer to minimize space requirements and provide ease of use.
The result is expensive and space consuming transport systems that are used to move various components throughout the analyzer.